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NCT Number: NCT01638416

Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.

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Key information

Conditions

Transfusion Age of Blood

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

About this study

Inclusion criteria

•Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion criteria

  • Age younger than 18
  • Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
  • Diagnosis of transplantation or hematologic diseases
  • Pregnancy
  • Cardiac surgery during the present hospital admission
  • Expected to die imminently (<24hrs)
  • The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
  • Known objection to the administration of human blood products
  • Participation in a competing study

Primary outcome- 90 day mortality

Secondary outcomes

  • 28 day mortality
  • Persistent Organ Dysfunction combined with death at 28
  • Days alive and free of mechanical ventilation at day 90 post randomisation
  • Day alive and free of renal replacement therapy at day 90 post randomisation
  • Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria
  • Length of stay in ICU and in hospital post randomisation
  • Febrile non-haemolytic transfusion reactions
  • EQ-5D score at Day 90 post randomisation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion criteria

  • Age younger than 18
  • Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
  • Diagnosis of transplantation or hematologic diseases
  • Pregnancy
  • Cardiac surgery during the present hospital admission
  • Expected to die imminently (<24hrs)
  • The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
  • Known objection to the administration of human blood products
  • Participation in a competing study (see below)

Treatment and study plan

Blood transfusion

Other

Blood transfusion in ICU patients aged 18 and over.

Primary outcomes

  1. Mortality at Day 90

    Time frame: 90 Day

    Mortality at Day 90

Secondary outcomes

  1. Mortality at Day 28

    Time frame: 28 day

    Mortality at day 28

  2. Persistent Organ Dysfunction Combined With Death Measured at Day 28

    Time frame: day 28

    Persistent Organ Dysfunction combined with death measured at day 28

  3. Days Alive and Free of Mechanical Ventilation

    Time frame: day 28

    Days alive and free of mechanical ventilation

  4. Day Alive and Free of Renal Replacement Therapy.

    Time frame: day 28

    Day alive and free of renal replacement therapy.

  5. Blood Stream Infection in ICU (Post Randomisation)

    Time frame: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)

    Blood stream infection in ICU (post randomisation) Time Frame is in Days

  6. Length of Stay in ICU and in Hospital Post Randomisation (Days)

    Time frame: Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3)

    Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days

  7. Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU

    Time frame: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)

    Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU

  8. EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation

    Time frame: Day 180

    EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Australian Red Cross
  • Finnish Red Cross Blood Service
  • Irish Blood Transfusion Service
  • King Abdulaziz Medical City
  • New Zealand Blood Service
  • University College Dublin

Registry information

Official study title

A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units

Acronym: TRANSFUSE

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2012
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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